RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether capecitabine is more effective than observation in treating biliary tract cancer.

PURPOSE: This randomized phase III trial is studying capecitabine to see how well it works compared with observation in treating patients with biliary tract cancer.

To determine whether adjuvant chemotherapy with capecitabine has any effect on 2-year survival compared to expectant treatment alone (observation) in patients who have undergone a macroscopically complete surgical resection of a biliary tract cancer.

Negative pregnancy test for women of childbearing age and childbearing potential

Fertile patients must use effective contraception during study treatment and for at least 3 months after study treatment has ended

Must provide written informed consent

No history of other malignant diseases within the past 5 years other than adequately treated nonmelanoma skin cancer or in situ carcinoma of the uterine cervix

No serious co-existing medical condition likely to interfere with protocol treatment, including a potential serious infection

No evidence of significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial

No psychological, familial, sociological, or geographical factors considered likely to preclude study compliance

No other serious uncontrolled medical conditions

No unresolved biliary tree obstruction

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Completely recovered from prior surgery

No use of other investigational agents within 28 days prior to and during study treatment

No prior chemotherapy or radiotherapy for biliary tract cancer

No other concurrent anticancer chemotherapy, radiotherapy, or investigational agent

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363584

localized resectable adult primary liver cancer
cholangiocarcinoma of the extrahepatic bile duct
cholangiocarcinoma of the gallbladder
adenocarcinoma of the gallbladder
adenocarcinoma with squamous metaplasia of the gallbladder